Exactech, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3209-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Product Classification:

Class II

Date Initiated: May 8, 2018

Date Posted: September 26, 2018

Recall Number: Z-3209-2018

Event ID: 80763

Reason for Recall:

Potentially have non-conforming internal threads.

Status: Ongoing

Product Quantity: 1

Code Information:

Catalog #: 02-012-60-2216 Serial Number: 5370045

Distribution Pattern:

US Distribution to Ohio only.

Voluntary or Mandated:

Voluntary: Firm initiated